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Trial Title:
Impact of Clinical Evident Portal Hypertension on HCC With TACE (CHANCE-CHESS 2301)
NCT ID:
NCT05703750
Condition:
Hepatocellular Carcinoma
Portal Hypertension
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Hypertension, Portal
Hypertension
Conditions: Keywords:
hepatocellular carcinoma
transarterial chemoembolization
clinical evident portal hypertension
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
TACE ± Systemic therapy
Description:
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE); Systemic therapy:
PD-1/PD-L1 inhibitors, VEGF-TKI/bevacizumab, PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab,
radiotherapy or chemotherapy.
Arm group label:
CEPH group
Arm group label:
non-CEPH group
Summary:
The purpose of this study is to discuss the prognostic value of CEPH among HCC patients
underwent TACE treatment, its impact on overall survival, and try to stratify patient
cohorts for a better treatment strategy.
Detailed description:
Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the second
leading cause of cancer-related deaths globally. Transarterial chemoembolization (TACE)
is recommended as standard therapy for intermediate-stage HCC according to the current
guidelines and is also the most widely used in advanced HCC in real-world practice.
Clinically relevant portal hypertension increases the risk of hepatic decompensation,
which impairs survival in patients with HCC. The purpose of this study is to discuss the
prognostic value of CEPH among HCC patients who underwent TACE treatment, its impact on
overall survival, and try to stratify patient cohorts for a better treatment strategy.
Criteria for eligibility:
Study pop:
Patients with HCC treated with TACE ± Systemic Treatment from June 2006 to December 2021.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Received at least 1 TACE treatment；
Exclusion Criteria:
1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed
hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are
not eligible;
2. ECOG Performance Score > 2;
3. History of spleen resection;
4. Loss to follow-up.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gao-Jun Teng
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu-Qing Wang
Facility:
Name:
Xiaolong Qi
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu-Qing Wang
Start date:
May 4, 2023
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Zhongda Hospital
Agency class:
Other
Source:
Zhongda Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05703750
